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CompletedNCT01686750Updated Jul 16, 2019Results posted

Integrated Care Centers to Improve HIV Outcomes in Vulnerable Indian Populations

An interventional study of Integrated care centers in HIV Infection, sponsored by Johns Hopkins University. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
21,726
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a cluster randomized trial to evaluate the effectiveness of integrated care centers (ICC) to improve access to HIV testing, prevention services, and treatment among high-risk populations of injection drug users (IDU) and men who have sex with men (MSM) in India. We will collect baseline ethnographic and survey data from approximately 27 IDU or MSM sites in India. We will use baseline data to select 22 sites for the trial (12 IDU and 10 MSM) and to stratify sites according to key baseline characteristics. We will perform stratified randomization to assign sites to either the ICC intervention or to standard services. ICCs, which will be either IDU or MSM-focused, will provide an accepting atmosphere in which members of vulnerable groups can drop-in, receive rapid HIV voluntary counselling and testing, risk reduction counseling and services, and antiretroviral therapy. ICCs will be scaled-up from existing governmental or non-governmental organizations and services provided at ICCs will be supported by the National AIDS Control Organization (NACO) of India. After providing services in communities for two years, we will conduct an evaluation survey (with biological and behavioral measures) of approximately 1000 subjects in the target populations in each of the 22 study sites. Integrated care centers have the potential to improve access to HIV prevention and treatment services among vulnerable, high-risk populations.

02

Conditions studied

  • HIV Infection

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Keywords

  • HIV
  • injection drug use
  • men who have sex with men
  • voluntary counselling and testing
  • risk reduction
  • sexually transmitted infections
  • community viral load
  • antiretroviral therapy
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 21,726 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.

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Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Key Informant Interviews:

Persons may be included in the key informant interviews if they meet all of the following criteria:

  1. 18 years of age or older
  2. Knowledge of the local HIV risk group of interest (IDU or MSM)
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Provide informed consent

Focus groups:

Persons may be included in the focus groups if they meet all of the following criteria:

  1. 18 years of age or older

  2. Member of a target HIV risk group, meeting criterion 2a or 2b

    1. IDU: self-reported injection drug use in prior 12 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Provide informed consent

Baseline or evaluation respondent-driven sampling (RDS) survey

Persons may be included in the baseline or evaluation RDS survey if they meet all of the following criteria:

  1. 18 years of age or older

  2. Member of a target HIV risk group, meeting criterion 2a or 2b

    1. IDU: self-reported injection drug use in prior 24 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Psychologically fit to participate in the study and to understand the consent
  4. Ability to comprehend one of the consent translation languages
  5. Present a valid RDS referral coupon (unless a seed)
  6. Provide informed consent

Exclusion criteria

Exclusion Criteria:

Key Informant Interviews:

Persons will be excluded from the key informant interviews if they meet any of the following criteria:

  1. Younger than 18 years
  2. Do not have knowledge of the local HIV risk group of interest (IDU or MSM)
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not provide informed consent

Focus groups:

Persons will be excluded from the focus groups if they meet any of the following criteria:

  1. Younger than 18 years

  2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

    1. IDU: self-reported injection drug use in prior 12 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not provide informed consent

Baseline or evaluation RDS survey

Persons will be excluded in the baseline or evaluation RDS survey if they meet any of the following criteria:

  1. Younger than 18 years

  2. Are not a member of a target HIV risk group, meeting neither criterion 2a nor 2b

    1. IDU: self-reported injection drug use in prior 24 months
    2. MSM: self-identify as male and report oral/anal sex with another male in prior 12 months
  3. Are not psychologically fit to participate in the study or to understand the consent
  4. Do not have ability to comprehend one of the consent translation languages
  5. Do not present a valid RDS referral coupon and are not a seed
  6. Do not provide informed consent
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
21,726 participants (actual)

Study arms

  • Experimental
    Integrated care centers

    Integrated care centers will provide HIV prevention and treatment services to high risk populations of IDU or MSM in an accepting and supportive environment. * HIV voluntary counseling and testing \& staging * Risk reduction services including free condoms, needle and syringe exchange, opiate substitution therapy * Substance abuse counseling * Sexually transmitted infection screening and treatment * Access to free antiretroviral therapy and adherence support * Peer community outreach

    Behavioral: Integrated care centers

  • No intervention
    Standard services

    In Standard Services sites, HIV testing, prevention, and treatment services will be available through standard venues. Government centers typically provide most HIV testing services and are the only source for free antiretroviral therapy. Non-governmental organizations typically provide prevention and risk reduction services.

Interventions

  • BehavioralIntegrated care centers
06

What researchers measure

Primary outcomes

  1. Proportion Reporting HIV Testing in the Prior 12 Months

    Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.

    Time frame: 2 years

Secondary outcomes

  1. Proportion of HIV-infected Participants Aware of Status

    Proportion of HIV-positive participants that were aware of their status at the time of the visit

    Time frame: 2 years

  2. Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months

    Time frame: 2 years

  3. Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy

    Time frame: 2 years

  4. Community Viral Load

    Average log(10) HIV RNA concentration among HIV-infected participants

    Time frame: 2 years

  5. Proportion of HIV-infected Participants With Suppressed HIV RNA

    Proportion of HIV-positive participants meeting criteria for antiretroviral therapy \[cluster of differentiation 4 (CD4) count \<350 cells/mm3 or current or past use of antiretroviral therapy)\] who have a suppressed viral load (HIV RNA \<150 copies/mL)

    Time frame: 2 years

  6. Prevalence of Recent HIV Infection

    Time frame: 2 years

  7. Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months

    Time frame: 2 years

  8. Proportion of IDU Reporting Drug Abstinence in Prior 6 Months

    Time frame: 2 years

  9. Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months

    Time frame: 2 years

  10. Number of Non-main Male Partners in Prior 6 Months in MSM

    Time frame: 2 years

  11. Proportion Reporting Substance Abuse Among MSM

    Time frame: 2 years

  12. Proportion With Depressive Symptoms

    Participants with Score \>=10 on Patient Health Questionnaire-9

    Time frame: 2 years

  13. Number of Unprotected Sexual Acts Reported by MSM

    Time frame: 2 years

  14. Vicarious Stigma as Assessed by 6-item Stigma Scale

    Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma

    Time frame: 2 years

  15. Proportion Reporting Spouse Ever Tested for HIV

    Time frame: 2 years

07

Results

Posted Jul 16, 2019

Participant flow

Recruited by respondent-driven sampling in 22 sites in India.

Participant flow — Overall Study
MilestoneIntegrated Care CentersStandard Services
Started1100110725
Completed1100110725
Not completed00

Outcome measures

PrimaryProportion Reporting HIV Testing in the Prior 12 Months

Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.

Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion Reporting HIV Testing in the Prior 12 Months
percentage of participantsIntegrated Care CentersStandard Services
Proportion Reporting HIV Testing in the Prior 12 Months36.9 (20.5 to 53.3)26.2 (4.7 to 37.3)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Prevalence ratio · p = 0.09 · Risk ratio (rr): 1.31 · 95% CI 0.95 to 1.81Therefore, the exponentiated coefficients for intervention status represent the prevalence ratio with 95% confidence interval (CI) and are interpreted as the relative percentage difference in the outcome associated with the intervention.
SecondaryProportion of HIV-infected Participants Aware of Status

Proportion of HIV-positive participants that were aware of their status at the time of the visit

Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of HIV-infected Participants Aware of Status
percentage of participantsIntegrated Care CentersStandard Services
Proportion of HIV-infected Participants Aware of Status65.2 (24 to 86.5)59.4 (14.4 to 97.4)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 1.08 · 95% CI 0.80 to 1.50
SecondaryProportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months
percentage of participantsIntegrated Care CentersStandard Services
Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months45.7 (3.5 to 73.9)40.8 (3.1 to 88.0)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 1.05 · 95% CI 0.61 to 1.81
SecondaryProportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy
percentage of participantsIntegrated Care CentersStandard Services
Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy57 (11.4 to 87)46.8 (2 to 95.1)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 1.36 · 95% CI 0.77 to 2.41
SecondaryCommunity Viral Load

Average log(10) HIV RNA concentration among HIV-infected participants

Time frame:
2 years

No measurements were reported for this outcome.

SecondaryProportion of HIV-infected Participants With Suppressed HIV RNA

Proportion of HIV-positive participants meeting criteria for antiretroviral therapy \[cluster of differentiation 4 (CD4) count \<350 cells/mm3 or current or past use of antiretroviral therapy)\] who have a suppressed viral load (HIV RNA \<150 copies/mL)

Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of HIV-infected Participants With Suppressed HIV RNA
percentage of participantsIntegrated Care CentersStandard Services
Proportion of HIV-infected Participants With Suppressed HIV RNA47.3 (6.7 to 78.6)46.7 (7.4 to 82.9)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 0.91 · 95% CI 0.65 to 1.28
SecondaryPrevalence of Recent HIV Infection
Time frame:
2 years

No measurements were reported for this outcome.

SecondaryProportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months
percentage of participantsIntegrated Care CentersStandard Services
Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months30.1 (2.4 to 30.8)31.8 (6.8 to 56.9)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio, log: 1.44 · 95% CI 0.42 to 4.93
SecondaryProportion of IDU Reporting Drug Abstinence in Prior 6 Months
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months
percentage of participantsIntegrated Care CentersStandard Services
Proportion of IDU Reporting Drug Abstinence in Prior 6 Months28.2 (10.4 to 72.9)16.5 (1.7 to 42.3)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio, log: 1.87 · 95% CI 0.49 to 7.16
SecondaryProportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months
percentage of participantsIntegrated Care CentersStandard Services
Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months56.2 (39.8 to 78.9)69.3 (41.7 to 84)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 0.91 · 95% CI 0.53 to 1.56
SecondaryNumber of Non-main Male Partners in Prior 6 Months in MSM
Time frame:
2 years
Reported as:
Mean · partners
Number of Non-main Male Partners in Prior 6 Months in MSM
partnersIntegrated Care CentersStandard Services
Number of Non-main Male Partners in Prior 6 Months in MSM3.0 (0.6 to 6.4)3.1 (1.5 to 8.0)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Mean difference (final values): 0.03 · 95% CI -4.2 to 4.2
SecondaryProportion Reporting Substance Abuse Among MSM
Time frame:
2 years

No measurements were reported for this outcome.

SecondaryProportion With Depressive Symptoms

Participants with Score \>=10 on Patient Health Questionnaire-9

Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion With Depressive Symptoms
percentage of participantsIntegrated Care CentersStandard Services
Proportion With Depressive Symptoms13.4 (1.2 to 26.9)18.2 (3.7 to 35.1)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 0.84 · 95% CI 0.47 to 1.52
SecondaryNumber of Unprotected Sexual Acts Reported by MSM
Time frame:
2 years

No measurements were reported for this outcome.

SecondaryVicarious Stigma as Assessed by 6-item Stigma Scale

Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma

Time frame:
2 years
Reported as:
Mean · score on a scale
Vicarious Stigma as Assessed by 6-item Stigma Scale
score on a scaleIntegrated Care CentersStandard Services
Vicarious Stigma as Assessed by 6-item Stigma Scale2.9 (2.1 to 4.2)4.6 (1.5 to 7.1)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Mean difference (final values): -1.8 · 95% CI -3.0 to -0.6
SecondaryProportion Reporting Spouse Ever Tested for HIV
Time frame:
2 years
Reported as:
Mean · percentage of participants
Proportion Reporting Spouse Ever Tested for HIV
percentage of participantsIntegrated Care CentersStandard Services
Proportion Reporting Spouse Ever Tested for HIV45.9 (19.2 to 74.3)46.8 (7.7 to 79.9)
Statistical analysis
  • Integrated Care Centers vs Standard Services · Risk ratio (rr): 0.93 · 95% CI 0.64 to 1.36

Adverse events

Collected over This study was based on cross-sectional surveys. Therefore adverse events were only documented at the time of the survey visit (1 day).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Integrated Care Centers0/11,001 (0%)0/11,001 (0%)0/11,001 (0%)
Standard Services0/10,725 (0%)0/10,725 (0%)0/10,725 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Integrated Care CentersStandard ServicesTotal
Median30 (24 to 34)29 (26 to 35)29 (24 to 35)
Sex: Female, Male
Sex: Female, Male(Participants)Integrated Care CentersStandard ServicesTotal
Female221272493
Male107801045321233
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Integrated Care CentersStandard ServicesTotal
American Indian or Alaska Native000
Asian110011072521726
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
At least secondary school education
At least secondary school education(Participants)Integrated Care CentersStandard ServicesTotal
Count of participants8729745516184
08

Study locations

1 site
  • YR Gaitonde Center for AIDS Research and Education
    Chennai, Tamil Nadu 600113, India
09

References and documents

Publications

  • Solomon SS, Mehta SH, Srikrishnan AK, Vasudevan CK, Mcfall AM, Balakrishnan P, Anand S, Nandagopal P, Ogburn EL, Laeyendecker O, Lucas GM, Solomon S, Celentano DD. High HIV prevalence and incidence among MSM across 12 cities in India. AIDS. 2015 Mar 27;29(6):723-31. doi: 10.1097/QAD.0000000000000602. PubMed 25849835 ↗
  • Lucas GM, Solomon SS, Srikrishnan AK, Agrawal A, Iqbal S, Laeyendecker O, McFall AM, Kumar MS, Ogburn EL, Celentano DD, Solomon S, Mehta SH. High HIV burden among people who inject drugs in 15 Indian cities. AIDS. 2015 Mar 13;29(5):619-28. doi: 10.1097/QAD.0000000000000592. PubMed 25715105 ↗
  • Solomon SS, Mehta SH, Srikrishnan AK, Solomon S, McFall AM, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Lucas GM, Kumar MS, Sulkowski MS, Quinn TC. Burden of hepatitis C virus disease and access to hepatitis C virus services in people who inject drugs in India: a cross-sectional study. Lancet Infect Dis. 2015 Jan;15(1):36-45. doi: 10.1016/S1473-3099(14)71045-X. Epub 2014 Dec 3. PubMed 25486851 ↗
  • Solomon SS, Lucas GM, Celentano DD, Sifakis F, Mehta SH. Beyond surveillance: a role for respondent-driven sampling in implementation science. Am J Epidemiol. 2013 Jul 15;178(2):260-7. doi: 10.1093/aje/kws432. Epub 2013 Jun 25. PubMed 23801014 ↗
  • Solomon SS, Lucas GM, Celentano DD, McFall AM, Ogburn E, Moulton LH, Srikrishnan AK, Kumar MS, Anand S, Solomon S, Mehta SH. Design of the Indian NCA study (Indian national collaboration on AIDS): a cluster randomized trial to evaluate the effectiveness of integrated care centers to improve HIV outcomes among men who have sex with men and persons who inject drugs in India. BMC Health Serv Res. 2016 Nov 14;16(1):652. doi: 10.1186/s12913-016-1905-5. PubMed 27842543 ↗
  • Mehta SH, Lucas GM, Solomon S, Srikrishnan AK, McFall AM, Dhingra N, Nandagopal P, Kumar MS, Celentano DD, Solomon SS. HIV care continuum among men who have sex with men and persons who inject drugs in India: barriers to successful engagement. Clin Infect Dis. 2015 Dec 1;61(11):1732-41. doi: 10.1093/cid/civ669. Epub 2015 Aug 6. PubMed 26251048 ↗
  • Solomon SS, Solomon S, McFall AM, Srikrishnan AK, Anand S, Verma V, Vasudevan CK, Balakrishnan P, Ogburn EL, Moulton LH, Kumar MS, Sachdeva KS, Laeyendecker O, Celentano DD, Lucas GM, Mehta SH; Indian National Collaboration on AIDS Study. Integrated HIV testing, prevention, and treatment intervention for key populations in India: a cluster-randomised trial. Lancet HIV. 2019 May;6(5):e283-e296. doi: 10.1016/S2352-3018(19)30034-7. Epub 2019 Apr 2. PubMed 30952565 ↗
  • Prabhu S, Mehta SH, McFall AM, Srikrishnan AK, Vasudevan CK, Lucas GM, Celentano DD, Solomon SS. Substance use is associated with condomless anal intercourse among men who have sex with men in India: a partner-level analysis. BMC Public Health. 2022 Apr 11;22(1):722. doi: 10.1186/s12889-022-13192-y. PubMed 35410326 ↗
  • Solomon SS, Quinn TC, Solomon S, McFall AM, Srikrishnan AK, Verma V, Kumar MS, Laeyendecker O, Celentano DD, Iqbal SH, Anand S, Vasudevan CK, Saravanan S, Thomas DL, Sachdeva KS, Lucas GM, Mehta SH. Integrating HCV testing with HIV programs improves hepatitis C outcomes in people who inject drugs: A cluster-randomized trial. J Hepatol. 2020 Jan;72(1):67-74. doi: 10.1016/j.jhep.2019.09.022. Epub 2019 Oct 8. PubMed 31604081 ↗
  • Solomon SS, Mehta SH, McFall AM, Srikrishnan AK, Saravanan S, Laeyendecker O, Balakrishnan P, Celentano DD, Solomon S, Lucas GM. Community viral load, antiretroviral therapy coverage, and HIV incidence in India: a cross-sectional, comparative study. Lancet HIV. 2016 Apr;3(4):e183-90. doi: 10.1016/S2352-3018(16)00019-9. Epub 2016 Mar 11. PubMed 27036994 ↗

Study documents

  • Protocol and statistical analysis plan · Nov 14, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01686750
Lead sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), YR Gaitonde Centre for AIDS Research and Education, Elton John AIDS Foundation
Responsible party
Sponsor
First posted
Sep 18, 2012
Start date
Oct 2012
Primary completion
Jun 2017
Completion
Jun 2017
Results posted
Jul 16, 2019
Last update
Jul 16, 2019

Study contacts

Gregory M Lucas, MD
principal investigator · Johns Hopkins University
Shruti Mehta, PhD
principal investigator · Johns Hopkins University
David D Celentano, ScD
principal investigator · Johns Hopkins University
Suniti Solomon, MD
principal investigator · YR Gaitonde Centre for AIDS Research and Education
Aylur Srikrishnan, BA
principal investigator · YR Gaitonde Centre for AIDS Research and Education
Suresh Kumar, MPH
principal investigator · YR Gaitonde Centre for AIDS Research and Education
Sunil S Solomon, PhD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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